BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    RUGGED AMB COT-LX

    MDR report key: 2100039 · Received May 16, 2011

    Report

    Report Number
    1831750-2011-04713
    Event Type
    Malfunction
    Date Received
    May 16, 2011
    Date of Event
    April 18, 2011
    Report Date
    April 18, 2011
    Manufacturer
    STRYKER MEDICAL
    Product Code
    FPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    BREAKAWAY HEAD SECTION.

    Description of Event or Problem · 1

    IT WAS REPORTED BY SERVICE REPORT THAT THE COT HAD A BREAKAWAY HEAD SECTION THAT WOULD NOT LOCK IN THE UPRIGHT POSITION DUE TO MISSING EXTENSION SPRINGS THAT INTERFACE WITH THE PIVOT ASSEMBLY. IT IS UNKNOWN IF THERE WAS PATIENT INVOLVEMENT OR IF THERE WERE ADVERSE CONSEQUENCES TO REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 RUGGED AMB COT-LX STRETCHER, WHEELED FPO STRYKER MEDICAL 6070 NA

    Patients

    Seq Age Sex Outcome Treatment
    1